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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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This is a single-blind (blinded expert grader), randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, antibiotic and benzoyl peroxide or benzoyl peroxide and adapalene gel and the contra lateral side of the face will remain non-treated to serve as a control. Approximately 25-30 male and female healthy subjects will be randomly assigned to each product
This is a single-blind (blinded expert grader), parallel group, randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, a topical antibiotic and benzoyl peroxide or benzoyl peroxide and adapalene and the contra lateral side of the face will remain non-treated to serve as a control. Approximately 25-30 male and female healthy subjects will be randomly assigned to each product.
The subjects will be entered into a 2-week treatment phase. The once-daily applications for the study medication will be supervised at the site, Monday through Friday of each week. Subjects will apply the study product at home on Saturdays and Sundays.
A blinded expert grader will rate comparative product tolerance on each week day (excluding Saturdays and Sundays) during the study before study product is applied.
Subject questionnaires will be completed along with collection of all adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinidamycin/ Benzoyl Peroxide | Experimental | Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide (BPO). |
|
| Benzoyl peroxide and adapalene | Active Comparator | Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide (BPO) and adapalene |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clindamycin and benzoyl peroxide | Drug | Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide gel. This contains a topical antibiotic and benzoyl peroxide gel. |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Erythema (Redness) | Assessment of erythema as part of an evaluation of tolerance of two treatments: clindamycin and benzoyl peroxide or dapsone gel. This was done by visual assessment by an independent blinded grader using the grading scale shown below. Grade Description 0 None 2 Mild erythema 4 Moderate confluent erythema 6 Marked erythema with some edema 8 Marked erythema, edema, possible erosion | Baseline, Day 1 through Day 14 |
| Skin Dryness | The amount of dryness on the left and right cheek of each panelist. The scale used to evaluate skin dryness is: Grade Description 0 None 2 Slight flaking 4 Moderate flaking/scaling 6 Marked scaling / slight fissuring 8 Severe scaling, fissuring Expert Grader assessments of dryness were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. | Baseline, Day 1 through Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Moisture and Hydration | To assess skin moisture and hydration using transepidermal water loss (TEWL). Results are measured on a continuous scale. Higher values indicate greater water loss/ lower skin moisture levels. Evaporative water loss measurements provide an instrumental assessment of skin barrier function(one of the layers of the skin. Damage leads to a disruption of the barrier that is accompanied by elevated water loss rates and affects skin moisture and hydration. Higher values indicate greater water loss. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| cyberDERM | Broomall | Pennsylvania | 19008 | United States |
Panelists who met the eligibility criteria and were willing to participate in the study were required to undergo a 3-day pre-trial conditioning period where they had to stop the use of all facial products. Panelists were required to use the provided Soap Free Cleanser (SFC) for washing their face and were allowed to apply their normal makeup.
Clinical research center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Duac | Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide |
| FG001 | Epiduo | Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Duac | Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide |
| BG001 | Epiduo | Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Skin Erythema (Redness) | Assessment of erythema as part of an evaluation of tolerance of two treatments: clindamycin and benzoyl peroxide or dapsone gel. This was done by visual assessment by an independent blinded grader using the grading scale shown below. Grade Description 0 None 2 Mild erythema 4 Moderate confluent erythema 6 Marked erythema with some edema 8 Marked erythema, edema, possible erosion | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Day 1 through Day 14 |
|
14 days
Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Duac | Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D002981 | Clindamycin |
| D001585 | Benzoyl Peroxide |
| D000068816 | Adapalene |
| D005782 | Gels |
| ID | Term |
|---|---|
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
| benzoyl peroxide 2.5% and adapalene 0.1% gel | Drug | Once-daily applications, to the randomized side of the face either left or right,benzoyl peroxide and adapalene gel |
|
|
| Baseline, Days 3, 7, and 14 |
| Skin Hydration | The ability of an alternating current to flow through the stratum corneum is an indirect measure of its water content. The value recorded is expressed in microsiemens. Higher values indicate greater levels of skin hydration. Test results were compared to measurements from the other side of the face, which was not treated instead of referring to a normal range. A normal range does not exist for this measurement. Instead, the non-treated side of the face was used as a control to determine the normal level of skin hydration. | Baseline, 4 hrs. post 1st Treatment, Days 3, 7, and 14 |
| Self Assessment of Burning | The amount of burning on the left and right cheek of each panelist. The scale used to evaluate burning is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. | Baseline, Day 1 through Day 14 |
| Self Assessment of Stinging | The amount of stinging on the left and right cheek of each panelist. The scale used to evaluate stinging is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of stinging were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. | Baseline, Day 1 through Day 14 |
| Self Assessment of Dryness | The amount of dryness on the left and right cheek of each panelist. The scale used to evaluate dryness is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. | Baseline, Day 1 through Day 14 |
| Self Assessment of Texture (Roughness) | The amount of roughness on the left and right cheek of each panelist. The scale used to evaluate roughness is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. | Baseline, Day 1 through Day 14 |
| Self Assessment of Pain | The amount of pain on the left and right cheek of each panelist. The scale used to evaluate pain is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. | Baseline, Day 1 through Day 14 |
| Self Assessment of Crusting | The amount of crusting on the left and right cheek of each panelist. The scale used to evaluate crusting is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. | Baseline, Day 1 through Day 14 |
| Self Assessment of Blistering | The amount of blistering on the left and right cheek of each panelist. The scale used to evaluate blistering is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. | Baseline, Day 1 through Day 14 |
| Self Assessment of Oiliness | The amount of oiliness on the left and right cheek of each panelist. The scale used to evaluate oiliness is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. | Baseline, Day 1 through Day 14 |
| Product Acceptability and Preference Questionnaire - How do You Rate the Comfort of the Skin Where You Are Currently Treating With the Study Product? | The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How do you rate the comfort of the skin where you are currently treating with the study product? The subject replied using the following scale:
| Day 14 |
| Product Acceptability and Preference Questionnaire - How Compliant Were You With Applying the Study Product Each and Every Day? | The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How compliant were you with applying the study product each and every day? The subject replied using the following scale: 0 - Not Compliant at all (<50%)
| Day 14 |
| Product Acceptability and Preference Questionnaire - Did You Feel That Your Skin Was Hydrated and Moisturized While You Were on Your Study Product? | The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product? The subject replied using the following scale: 1 - Yes 0 - No | Day 14 |
| Product Acceptability and Preference Questionnaire - Was the Study Product Easy to Use With Make-up? | The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up? The subject replied using the following scale: 0 - Not Applicable
| Day 14 |
| Product Acceptability and Preference Questionnaire - What Was Your Overall Satisfaction of the Study Product? | The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: What was your overall satisfaction of the study product? The subject replied using the following scale:
| Day 14 |
| Product Acceptability and Preference Questionnaire - How do You Rate the Ease of Application of the Study Product? | The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up? The subject replied using the following scale: 0 - Not Applicable
| Day 14 |
| Skin Irritation |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Skin Moisture and Hydration | To assess skin moisture and hydration using transepidermal water loss (TEWL). Results are measured on a continuous scale. Higher values indicate greater water loss/ lower skin moisture levels. Evaporative water loss measurements provide an instrumental assessment of skin barrier function(one of the layers of the skin. Damage leads to a disruption of the barrier that is accompanied by elevated water loss rates and affects skin moisture and hydration. Higher values indicate greater water loss. | Posted | Mean | Standard Deviation | TEWL rates (gm/m2/hr) | Baseline, Days 3, 7, and 14 |
|
|
|
| Primary | Skin Dryness | The amount of dryness on the left and right cheek of each panelist. The scale used to evaluate skin dryness is: Grade Description 0 None 2 Slight flaking 4 Moderate flaking/scaling 6 Marked scaling / slight fissuring 8 Severe scaling, fissuring Expert Grader assessments of dryness were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 1 through Day 14 |
|
|
|
|
| Secondary | Skin Hydration | The ability of an alternating current to flow through the stratum corneum is an indirect measure of its water content. The value recorded is expressed in microsiemens. Higher values indicate greater levels of skin hydration. Test results were compared to measurements from the other side of the face, which was not treated instead of referring to a normal range. A normal range does not exist for this measurement. Instead, the non-treated side of the face was used as a control to determine the normal level of skin hydration. | Posted | Mean | Standard Deviation | Microsiemens | Baseline, 4 hrs. post 1st Treatment, Days 3, 7, and 14 |
|
|
|
| Secondary | Self Assessment of Burning | The amount of burning on the left and right cheek of each panelist. The scale used to evaluate burning is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 1 through Day 14 |
|
|
|
| Secondary | Self Assessment of Stinging | The amount of stinging on the left and right cheek of each panelist. The scale used to evaluate stinging is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of stinging were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 1 through Day 14 |
|
|
|
| Secondary | Self Assessment of Dryness | The amount of dryness on the left and right cheek of each panelist. The scale used to evaluate dryness is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 1 through Day 14 |
|
|
|
| Secondary | Self Assessment of Texture (Roughness) | The amount of roughness on the left and right cheek of each panelist. The scale used to evaluate roughness is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 1 through Day 14 |
|
|
|
| Secondary | Self Assessment of Pain | The amount of pain on the left and right cheek of each panelist. The scale used to evaluate pain is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 1 through Day 14 |
|
|
|
| Secondary | Self Assessment of Crusting | The amount of crusting on the left and right cheek of each panelist. The scale used to evaluate crusting is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 1 through Day 14 |
|
|
|
| Secondary | Self Assessment of Blistering | The amount of blistering on the left and right cheek of each panelist. The scale used to evaluate blistering is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 1 through Day 14 |
|
|
|
| Secondary | Self Assessment of Oiliness | The amount of oiliness on the left and right cheek of each panelist. The scale used to evaluate oiliness is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 1 through Day 14 |
|
|
|
| Secondary | Product Acceptability and Preference Questionnaire - How do You Rate the Comfort of the Skin Where You Are Currently Treating With the Study Product? | The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How do you rate the comfort of the skin where you are currently treating with the study product? The subject replied using the following scale:
| Posted | Mean | Standard Deviation | units on a scale | Day 14 |
|
|
|
| Secondary | Product Acceptability and Preference Questionnaire - How Compliant Were You With Applying the Study Product Each and Every Day? | The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How compliant were you with applying the study product each and every day? The subject replied using the following scale: 0 - Not Compliant at all (<50%)
| Posted | Mean | Standard Deviation | units on a scale | Day 14 |
|
|
|
| Secondary | Product Acceptability and Preference Questionnaire - Did You Feel That Your Skin Was Hydrated and Moisturized While You Were on Your Study Product? | The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product? The subject replied using the following scale: 1 - Yes 0 - No | Posted | Mean | Standard Deviation | units on a scale | Day 14 |
|
|
|
| Secondary | Product Acceptability and Preference Questionnaire - Was the Study Product Easy to Use With Make-up? | The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up? The subject replied using the following scale: 0 - Not Applicable
| Posted | Mean | Standard Deviation | units on a scale | Day 14 |
|
|
|
| Secondary | Product Acceptability and Preference Questionnaire - What Was Your Overall Satisfaction of the Study Product? | The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: What was your overall satisfaction of the study product? The subject replied using the following scale:
| Posted | Mean | Standard Deviation | units on a scale | Day 14 |
|
|
|
| Secondary | Product Acceptability and Preference Questionnaire - How do You Rate the Ease of Application of the Study Product? | The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up? The subject replied using the following scale: 0 - Not Applicable
| Posted | Mean | Standard Deviation | units on a scale | Day 14 |
|
|
|
| 0 |
| 25 |
| 13 |
| 25 |
| EG001 | Epiduo | Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene | 0 | 27 | 13 | 27 |
| Irritation | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Seaonal allergies | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Menstrual cramps | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Toothache | General disorders | MedDRA | Non-systematic Assessment |
|
| Sore throat | General disorders | MedDRA | Non-systematic Assessment |
|
| Earache | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Stitches contusion | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Scratched cornea | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
Not provided
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| D006571 |
| Heterocyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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